1. Field of the Invention
The present invention relates generally to apparatus and methods for utilizing and monitoring traction-based therapy, and specifically in one exemplary aspect to a mobile cervical spine brace and traction device which is able to provide electronic data regarding use to a patient and/or operator.
2. Description of Related Technology
By age 55, about 95% of the population will experience some degenerative condition of the cervical spine that may cause neck pain and/or upper extremity pain and as much as one-third of that group may experience weakness. These non-tumorous and non-infectious conditions may include degenerative intervertebral discs, disc herniations, internal disc disruption, vertebral osteophytes or spur formation and spondylolisthesis, and they may potentially result in loss of disc space, height, encroachment on spinal nerve roots where they exit the spinal cord (radiculopathy), regional spinal cord compression (myelopathy) or vertebral joint instability. Moreover, yearly work-injury-related neck and/or back pain may frequently affect as much as 15 to 20% of the workforce; for example, the 1990 annual cost of neck and lower back care in the United States reached a staggering $85 billion.
Management of cervical pain, radiculopathy and myelopathy is either surgical or conservative; these surgical or conservative approaches may include anti-inflammatory medications, physical therapy, immobilization and traction. Surgical patients are always at risk for surgical complications including resultant quadriplegia and even death. Many recent publications by surgical and conservative therapists have, both retrospectively and prospectively, compared short and long term outcomes between the two treatment groups, and the consensus appears to be that, in the majority of patients, the outcomes are not truly distinguishable at one year. Further, an intervention that would hasten the conservative recovery process, such as by facilitating independent patient participation in his/her own care, would result in significant healthcare cost savings.
Cervical traction is a technique where the weight of the head is removed from the cervical spinal axis and the cervical column is stretched in order to relieve stress within the neck. This method can temporarily remove much of the pain experienced by people with cervical disorders. Traction devices are well known in the medical field to facilitate the accomplishment of the following: (i) regaining normal length and alignment of involved bone, (ii) reducing and immobilizing fractured bone, (iii) lessening or eliminating muscle spasms, (iv) relieving pressure on nerves, especially spinal nerves, and (v) preventing or reducing skeletal deformities or muscle contractures. However, most of the currently available traction devices are very cumbersome and difficult to use. Also, many must be used with direct interaction with a physician or other healthcare provider and, therefore, deny the patient mobility when in traction. Because these problems often affect the everyday lives of these patients, a portable traction device that can be used while the person goes about his daily tasks can prove to be a far better solution.
Previous mechanical efforts to support the cervical spine or apply traction thereto have generally fallen into certain distinct design categories.
One such category includes cervical collars that incorporate single or multiple, stacked pneumatic/air bladders. These devices are shown at inter alia, U.S. Pat. No. 6,050,965; U.S. Pat. No. 7,048,705; U.S. Pat. No. 5,752,927; U.S. Pat. No. 3,765,412; U.S. Pat. No. 6,059,548; U.S. Pat. No. 6,899,690; U.S. Pat. No. 6,447,468; U.S. Pat. No. 5,916,185; U.S. Pat. No. 5,454,781; U.S. Pat. No. 5,441,479; U.S. Pat. No. 5,569,176; and U.S. Pat. No. 3,343,532. Cervical collars incorporating multiple, stacked, fluid-filled bladders are shown at, inter alia, U.S. Pat. No. 5,823,982; and U.S. Pat. No. 5,403,266. The solid nature of the above mentioned collars makes such apparatus difficult for a patient to use while engaging in other activities. Furthermore, the use of fluid or air filled bladders typically renders the prior art devices non-durable thereby impeding a user from participating in various common activities during traction therapy.
A full, but open, cervical collar, attached to a heavy chest/back apron/harness by adjustable spring-loaded rods is shown in U.S. Pat. No. 6,045,522; whereas U.S. Pat. No. 3,776,224 shows a similar spring-tensioned device. Such devices again disrupt a patient's ability to engage in normal activities while wearing the device as well as require physician or other professional operation.
U.S. Pat. No. 2,102,069 shows spaced pads carried by independent side braces that are angularly adjustable and are also longitudinal adjustable via sliding members and clamping screws. Threaded rod adjusters are shown in U.S. Pat. No. 2,736,314; U.S. Pat. No. 2,820,455; and U.S. Pat. No. 3,177,869. U.S. Pat. No. 5,046,490 places a peg in a hole on a sliding bar to fix the length and employs a hinge mechanism to control abduction in one embodiment and, in another, uses nuts on a threaded rod to cause a collar to slide up and down.
A rack and pinion system is shown in U.S. Pat. No. 2,791,999. A halo to skull fixation device is attached to shoulder harness by calibrated threaded rods in U.S. Pat. No. 5,195,947 and in U.S. Pat. No. 5,697,894.
A full collar with a tracheal core aperture designed for static support and emergency immobilization is shown in U.S. Pat. No. 4,886,052 and a full collar with a ratchet and pawl mechanism for improved fit, emergency immobilization is shown in U.S. Pat. No. 6,036,664.
U.S. Pat. No. 5,651,754 illustrates a device for reforming the spine which utilizes a belt that is tightened about the waist and a motor-driven vertical rod that spaces a brace that engages the arm pits or the chin.
U.S. Pat. No. 6,875,189 to Nelson shows a cervical traction device which utilizes, inter alia, a hinge to attach the occipital support to the main body. U.S. Pat. No. 6,599,257 illustrates a cervical therapy device which allows rotation about two perpendicular axes and linear movement along one of these axes.
Despite the breadth of the foregoing variations, there is a need for improved apparatus and methodology for traction-based therapy. Such improved apparatus and methodology would ideally provide a patient with a user-friendly, simple, lightweight, easily installed and easily adjusted device which allows the application of appropriate, effective and efficient cervical traction by the patient in any setting; e.g., while the patient is an upright, mobile position, or while still permitting continuous passive motion by the patient (such as e.g., allowing them to rotate their head to either side).
Such apparatus and methods would furthermore advantageously implement data collection and transmission elements, as well as be adapted to provide a physician, physical therapist, chiropractor or other healthcare provider (or even the patient themselves) with the ability to program in the apparatus a regimen for the patient to follow, as well as incorporate monitoring functionality for the healthcare provider.